Application 216023

Type: NDA
Sponsor: BLUE EARTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POSLUMA	FLOTUFOLASTAT F-18 GALLIUM	SOLUTION;INTRAVENOUS	25ML (8-158mCi/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N216023-001	POSLUMA	FLOTUFOLASTAT F-18 GALLIUM	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-05-25

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216023-001	12390540	2038-08-23		Drug substance	2025-09-03
N216023-001	11413360	2038-11-22	U-3614	Drug substance	2023-06-06
N216023-001	11413360	2038-11-22	U-3615	Drug substance	2023-06-06
N216023-001	12357711	2038-11-22		Drug substance	2025-08-06
N216023-001	12377176	2038-11-22		Drug substance	2025-09-03
N216023-001	12036290	2041-11-27	U-3614	Drug product	2024-08-01
N216023-001	12036290	2041-11-27	U-3615	Drug product	2024-08-01
N216023-001	12427207	2041-11-27		Drug product	2025-10-20

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216023-001	NCE	2028-05-25

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216023-001	POSLUMA	50ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N216023-001	POSLUMA	50ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216023-001	POSLUMA	25ML (8-158mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-25	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N216023-001	12390540	2038-08-23		Drug substance	2025-09-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216023-001	11413360	2038-11-22	U-3614	Drug substance	2023-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216023-001	11413360	2038-11-22	U-3615	Drug substance	2023-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216023-001	12357711	2038-11-22		Drug substance	2025-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216023-001	12377176	2038-11-22		Drug substance	2025-09-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216023-001	12036290	2041-11-27	U-3614	Drug product	2024-08-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216023-001	12036290	2041-11-27	U-3615	Drug product	2024-08-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216023-001	12427207	2041-11-27		Drug product	2025-10-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216023-001	12390540	2038-08-23		Drug substance	2025-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216023-001	11413360	2038-11-22	U-3614	Drug substance	2023-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216023-001	11413360	2038-11-22	U-3615	Drug substance	2023-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216023-001	12357711	2038-11-22		Drug substance	2025-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216023-001	12377176	2038-11-22		Drug substance	2025-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216023-001	12036290	2041-11-27	U-3614	Drug product	2024-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216023-001	12036290	2041-11-27	U-3615	Drug product	2024-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216023-001	12427207	2041-11-27		Drug product	2025-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216023-001	12390540	2038-08-23		Drug substance	2025-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216023-001	11413360	2038-11-22	U-3614	Drug substance	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216023-001	11413360	2038-11-22	U-3615	Drug substance	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216023-001	12357711	2038-11-22		Drug substance	2025-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216023-001	12377176	2038-11-22		Drug substance	2025-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216023-001	12036290	2041-11-27	U-3614	Drug product	2024-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216023-001	12036290	2041-11-27	U-3615	Drug product	2024-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216023-001	12427207	2041-11-27		Drug product	2025-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216023-001	12390540	2038-08-23		Drug substance	2025-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216023-001	11413360	2038-11-22	U-3614	Drug substance	2023-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216023-001	11413360	2038-11-22	U-3615	Drug substance	2023-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216023-001	12357711	2038-11-22		Drug substance	2025-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216023-001	12377176	2038-11-22		Drug substance	2025-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216023-001	12036290	2041-11-27	U-3614	Drug product	2024-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216023-001	12036290	2041-11-27	U-3615	Drug product	2024-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216023-001	12427207	2041-11-27		Drug product	2025-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216023-001	11413360	2038-11-22	U-3614	Drug substance	2023-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216023-001	11413360	2038-11-22	U-3615	Drug substance	2023-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216023-001	12036290	2041-11-27	U-3614	Drug product	2024-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216023-001	12036290	2041-11-27	U-3615	Drug product	2024-08-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216023-001	11413360	2038-11-22	U-3614	Drug substance	2023-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216023-001	11413360	2038-11-22	U-3615	Drug substance	2023-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216023-001	12036290	2041-11-27	U-3614	Drug product	2024-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216023-001	12036290	2041-11-27	U-3615	Drug product	2024-08-01	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N216023-001	NCE	2028-05-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216023-001	NCE	2028-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216023-001	NCE	2028-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216023-001	NCE	2028-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216023-001	NCE	2028-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216023-001	NCE	2028-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216023-001	NCE	2028-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216023-001	NCE	2028-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216023-001	NCE	2028-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216023-001	NCE	2028-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216023-001	NCE	2028-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216023-001	NCE	2028-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216023-001	NCE	2028-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216023-001	NCE	2028-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216023-001	NCE	2028-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216023-001	NCE	2028-05-25	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216023-001	NCE	2028-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216023-001	NCE	2028-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216023-001	NCE	2028-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216023-001	NCE	2028-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216023-001	NCE	2028-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216023-001	NCE	2028-05-25	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216023-001	NCE	2028-05-25	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POSLUMA	FLOTUFOLASTAT F-18	Blue Earth Diagnostics	907ac4a4-a088-4826-ab50-cfc31985c9d4	2026-07-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216023 application number: NDA216023

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80825	SUPPL	2025-01-10
74464	ORIG	2023-06-09
74386	ORIG	2023-05-26
74381	ORIG	2023-05-26